FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
15745–15768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2021
RMU-2000 Automated Chest Compression System
K211289 · DRM
Defibtech, LLC
Cardiovascular · 195d
Cleared Nov 09, 2021
Comby EEG Caps
K211315 · GXY
Pamel D.O.O
Neurology · 193d
Cleared Nov 09, 2021
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT,...
K211517 · GEX
Convergent Laser Technologies
General & Plastic Surgery · 176d
Cleared CT Nov 09, 2021
Vektor Computational ECG Mapping System (vMap)
K211546 · DQK
Vektor Medical, Inc.
Cardiovascular · 174d
Cleared Nov 09, 2021
Sensual Massage, Ultra Pure
K211967 · NUC
Dreambrands, Inc.
Obstetrics & Gynecology · 138d
Cleared Nov 09, 2021
BodySculp
K212331 · PKT
Rohrer Aesthetics, LLC
General & Plastic Surgery · 105d
Cleared Nov 09, 2021
Surgical Face Mask
K212526 · FXX
Suzhou Janee Medical Technology Co.,...
General Hospital · 90d
Cleared Nov 09, 2021
WHILL Model C2
K213383 · ITI
Whill, Inc.
Physical Medicine · 27d
Cleared Nov 08, 2021
Highspeed Airturbine Handpiece
K202371 · EFB
Beijing Dongbo Dental Handpiece Co.,...
Dental · 446d
Cleared Nov 08, 2021
Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen...
K203067 · DWF
Qura S.R.L
Cardiovascular · 395d
Cleared Nov 08, 2021
ST AIA-PACK BNP Assay
K211199 · NBC
Tosoh Bioscience, Inc.
Chemistry · 200d
Cleared Nov 08, 2021
GIQuant
K211356 · LLZ
Motilent, Ltd.
Radiology · 189d
Cleared Nov 08, 2021
Biotech Dental Kits
K212068 · KCT
Biotech Dental, Sas
General Hospital · 129d
Cleared Nov 08, 2021
Hura CTP v1.0
K212550 · LLZ
Hura Imaging, Inc.
Radiology · 87d
Cleared Nov 08, 2021
GT5 conductive & abrasive gel
K212787 · GYB
Wuhan Greentek Pty , Ltd.
Neurology · 68d
Cleared Nov 08, 2021
Paragon 28 External Ring Fixation System
K212895 · KTT
Paragon 28, Inc.
Orthopedic · 59d
Cleared Nov 08, 2021
FDR Cross (DR-XD 3000)
K212956 · OWB
Fujifilm Corporation
Radiology · 53d
Cleared Nov 07, 2021
Isolation Gown AAMI Level 3
K212504 · FYC
Kenpax International Limited
General Hospital · 90d
Cleared Nov 07, 2021
Medical Examination Gloves (Tested for Use with Chemotherapy)
K212506 · LZA
Guangdong Gymda Medical Technology...
General Hospital · 90d
Cleared Nov 05, 2021
MStim Drop Model: LGT-233
K202110 · GZI
Guangzhou Longest Science &...
Neurology · 463d
Cleared Nov 05, 2021
Disposable Medical Face Mask
K202676 · FXX
Zhejiang Senhong Medical&Instrument...
General Hospital · 416d
Cleared Nov 05, 2021
Best Glove-Latex Powder Free Examination Glove
K210253 · LYY
Bestsafe Glove Co., Ltd.
General Hospital · 280d
Cleared Nov 05, 2021
NextAR™ Spine Platform
K210859 · SBF
Medacta International S.A.
Orthopedic · 227d
Cleared Nov 05, 2021
Microcurrent device (Model: HBR2-1)
K211055 · NFO
Shenzhen DJ Medical Equipment Co., Ltd.
Neurology · 210d